Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
Phase 3
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00083954
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 530
Inclusion Criteria
- Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status
Exclusion Criteria
- More than 8 mood episodes in the past year from screen (visit 1);
- A current Axis I disorder other than bipolar disorder within 6 months of screening;
- patients with clinically significant abnormal laboratory findings in the investigator's judgment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
- Secondary Outcome Measures
Name Time Method Evaluate the incidence of treatment-emergent mania compared to placebo
Trial Locations
- Locations (1)
Research Site
🇺🇸Seattle, Washington, United States